Dr. Laura Fochtmann presented to the U.S. Food and Drug Administration Neurological Devices Panel examining the reclassification of electroconvulsive therapy (ECT) devices on January 27, 2011. These are her remarks as published in the public record of the meeting.
My name is Laura Fochtmann. I appreciate the opportunity to give testimony to the Panel today. I’m a board certified psychiatrist, a professor in the Department of Psychiatry and Behavioral Science and Director of the ECT Service at Stony Brook University Medical Center. I am also a member of the American Psychiatric Association Task Force on ECT, and I serve as the medical editor for the APA Practice Guidelines. My department is reimbursed by the APA for my guideline-related work, and my travel expenses today are also reimbursed by APA. I have no relationships with industry.
My interest in ECT dates back to my days as a medical student over 30 years ago, and I can still picture one of my patients, an emaciated woman who spent countless hours sitting at the edge of her bed staring into space. When the attending physician mentioned the possibility of ECT, I will admit to having some trepidation, but I quickly saw that ECT bore no resemblance to its movie portrayals, and just a week after her first ECT, my despondent patient was playing cards and joking with the others on the unit.
This experience and others like it crystallized my interest in becoming a psychiatrist. It showed me the impact of serious psychiatric illness, on our thinking, our feeling, and our abilities to do the things that we want to do. It also showed me how psychiatric treatment such as ECT could allow individuals to function again and experience the positive things in life.
I’ve subsequently seen many patients whose symptoms have not responded to other treatments but have responded to ECT, and without ECT, some of these individuals would have had much longer periods of suffering, sometimes ending in death due to poor food intake, prolonged immobility, or suicide. If ECT were not available, it would be tragic for many individuals and for those who care about them.
One of the key issues of this hearing relates to the efficacy of ECT. In my work as medical editor of the Practice Guidelines, I do systematic reviews and develop practice guideline recommendations for the treatment of psychiatric disorders, and through this work I have reviewed the evidence of ECT efficacy that come from meta-analyses, studies of different ECT techniques, post-ECT continuation treatments, or concomitant ECT and medication.
The speed and rate of symptom response and episode remission in these studies are particularly impressive since enrolled patients have severe symptoms or treatment-resistant episodes. The findings from older studies and meta-analyses of ECT as compared to sham ECT also show the efficacy of ECT, and I think these latter data are sufficiently strong that it would be ethically difficult to justify additional studies of the sort that are typically needed for premarket approval.
As with any treatment for a severe medical illness, ECT does not always work, and it can be associated with side effects which are sometimes significant. However, when administered by appropriately trained and privileged psychiatrists and anesthesiologists, ECT is a generally safe treatment. For a substantial number of patients, the benefits of ECT clearly outweigh the disadvantages, and as part of the informed consent process, we describe these anticipated benefits and risks of ECT, compare them to other treatment options, and review the steps of the anesthetic and ECT procedure.
Our goal is for the patient, and his or her involved family members, to think about the available options and make a collaborative decision based on his or her own circumstances and treatment preferences. In fact, as mental health consumers have become more educated about treatment options, we have seen increasing numbers of requests for ECT from patients who want relief from their intractable symptoms. And, thus, even though some people have strong negative opinions about ECT, others very much want ECT and feel positively about it as a treatment.
In closing, let me reiterate, psychiatric illnesses can be associated with extremely severe symptoms and can have very poor outcomes without effective treatment. ECT is an effective and important treatment option which can be particularly crucial for those with depressive or manic episodes, catatonia, or psychosis that is severe and life-threatening or unresponsive to other treatments. Future research will allow refinement in ECT technique that will enhance benefits and reduce side effects of ECT, but this should not take away from the fact that the efficacy and overall safety of ECT are already clear.
Thank you again for allowing me to speak with you today. I’m happy to answer any questions.